1270 Development of Clinical Standard Operating Procedures

X428.7 NATSC

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Course Description:

The U.S. federal regulations and ICH guidelines for good clinical practice require that all institutions and entities involved in research with human subjects develop and maintain written standard operating procedures (SOPs). However, many companies do not develop policies and SOPs until after human clinical trials are well underway. This course, aimed at clinical research associates, clinical research managers, and clinical operations directors and associate directors, examines the regulatory requirements and the differences between regulations, guidelines, policies and SOPs, and evaluates the components of a well-constructed SOP. Participants develop SOPs for critical clinical functions, such as safety reporting and data handling.

Prerequisite(s):

"Good Clinical Practices" or equivalent course or experience.

Applies Towards the Following Certificate(s) & Award(s):

Certificate Program in Clinical Trials Design and Management

Accrediting Associations:

CA BRN/LVN Credit - Provider #CEP13114 15.0 Hours

Sections:

1270 - 015 Development of Clinical Standard Operating Procedures

Status: Available

Section Note(s):Early Enrollment Fee: ($522 through Mar. 14).
Although not required, students are encouraged to bring a laptop computer and a copy of the Code of Federal Regulations, ICH Guidelines to class if available.
There is a new method for obtaining materials for this course. For details, please see ucsc-extension.edu/course-materials.

For Credit 1.5 Units
Mon, Tue 8:30AM to 5:00PM
Mar 28, 2011 to Mar 29, 2011
Number of Sessions: 2

Required Text(s): None

Recommended Text(s): None

Tuition:	$580.00
Early Enrollment	$522.00

Method of Instruction: LAB
Campus: SANTA CLARA

Instructor(s):

JACQUIE MARDELL, B.A.